(29 days)
Not Found
No
The summary describes a mechanical microcatheter and its physical properties, with no mention of AI/ML, image processing, or data-driven performance metrics.
Yes
The device aids in medical procedures by facilitating the placement of guide wires and assisting in the delivery of contrast media, which are actions performed during medical treatment or diagnosis, thus making it a therapeutic device.
No
The device is a microcatheter intended to facilitate the placement and exchange of guidewires and to assist in the delivery of contrast media, which are interventional and delivery functions, not diagnostic ones.
No
The device description explicitly lists physical components (distal tip, shaft tube, protector, connector) and the performance studies are focused on physical properties and mechanical testing of these components, indicating it is a hardware device.
Based on the provided information, the ASAHI Corsair Armet 18 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for providing support to facilitate the placement of guide wires and assisting in the delivery of contrast media in the peripheral vasculature. This is an in vivo application, meaning it is used within a living organism.
- Device Description: The description details a physical device (distal tip, shaft tube, protector, connector) designed for insertion into blood vessels.
- Anatomical Site: The specified anatomical site is the peripheral vasculature, which is part of the circulatory system within the body.
- Performance Studies: The performance studies focus on physical and mechanical properties relevant to a device used within the body (e.g., burst pressure, kink resistance, tensile strength, torque transmission).
IVD devices are used in vitro (outside of the body) to examine specimens such as blood, urine, or tissue to diagnose diseases or other conditions. The ASAHI Corsair Armet 18 does not fit this description.
N/A
Intended Use / Indications for Use
The ASAHI Corsair Armet 18 is intended to provide support to facement of guidewires in the peripheral vasculature, and can be used to exchange one guide wire for another.
The ASAHI Corsair Armet 18 is also intended to assist in the delivery of contract media into the peripheral vasculature.
This device should not be used in coronary vasculature or neurovasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
This product consists of a distal tip, a shaft tube, a protector and a connector. The distal tip and distal side of shaft are coated with hydrophilic coating on the outer surface. The tip is radiopaque, and the distal end is clearly distinguished by the tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non Clinical Laboratory testing performed on the ASAHI Corsair Armet 18 Microcatheter to determine substantial equivalence:
- Air Leakage
- Appearance / Dimensions
- Burst Pressure Under Static Condition
- Corrosion Resistance
- Kink Resistance
- Liquid Leakage Under Pressure
- Radio-Detectability
- Slide Durability
- Tensile Strength / Force at Break
- Torque Durability
- Torque Transmission
In the in vitro bench tests demonstrated that the ASAHI Corsair Armet 18 Microcatheter met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrates that the device functions as intended, and is substantially equivalent to the predicate device.
All bench testing of the ASAHI Corsair Armet 18 Microcatheter performed on finished sterilized product. The acceptance criteria is based on ISO10555-1. Tests not conducted per ISO10555-1 were completed using in-house validated procedures with internally developed acceptance criteria.
All ASAHI Corsair Armet 18 Microcatheter test samples met the acceptance criteria for each of the tests listed in this submission. There were no deviations from the acceptance criteria. Testing shows that the ASAHI Corsair Armet 18 Microcatheter is equivalent to the predicate ASAHI Corsair Armet.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
September 8, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Asahi Intecc Co., Ltd. Cynthia Valenzuela Director, Regulatory Affairs 3002 Dow Avenue, Suite 212 Tustin, California 92780
Re: K202252
Trade/Device Name: ASAHI Corsair Armet 18 Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: July 31, 2020 Received: August 10, 2020
Dear Cynthia Valenzuela:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medical-devices/ device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-andcontinuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance/contact-usdivision-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202252
Device Name ASAHI Corsair Armet 18
Indications for Use (Describe)
The ASAHI Corsair Armet 18 is intended to provide support to facement of guidewires in the peripheral vasculature, and can be used to exchange one guide wire for another.
The ASAHI Corsair Armet 18 is also intended to assist in the delivery of contract media into the peripheral vasculature.
This device should not be used in coronary vasculature or neurovasculature.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(K) Summary K202252
In accordance with the Safety Medical Devices Act of 1990 (SMDA), a 510(K) Summary of safety and effectiveness information upon which this substantial equivalence determination is based, is provided in this section.
| DATE PREPARED: | 31JUL2020 |
|---|---|
| APPLICANT: | ASAHI INTECC CO., LTD |
| 3-100 Akatsuki-cho, Seto | |
| Aichi 489-0071, Japan | |
| PRIMARY CONTACT: | Mrs. Cynthia Valenzuela |
| Director, Regulatory Affairs | |
| ASAHI INTECC USA, INC. | |
| 3002 Dow Avenue, Suite 212 | |
| Tustin, California 92780 | |
| Phone: (714) 442 0575 | |
| Fax: (949) 377 3255 | |
| Email: cynthiav@asahi-intecc-us.com | |
| TRADE NAME: | ASAHI Corsair Armet 18 |
| DEVICE CLASSIFICATION: | Class II, 21CFR§870.1250 |
| CLASSIFICATION NAME: | Percutaneous Catheter |
| PRODUCT CODE: | DQY, Catheter, Percutaneous |
| PREDICATE DEVICE(S): | ASAHI Corsair Armet (K161362) |
Intended Use/Indications for Use
The ASAHI Corsair Armet 18 is intended to provide support to facilitate the placement of guide wires in the peripheral vasculature, and can be used to exchange one guide wire for another.
The ASAHI Corsair Armet 18 is also intended to assist in the delivery of contract media into the peripheral vasculature.
This device should not be used in coronary vasculature or neurovasculature.
Device Description:
This product consists of a distal tip, a shaft tube, a protector and a connector. The distal tip and distal side of shaft are coated with hydrophilic coating on the outer surface. The tip is radiopaque, and the distal end is clearly distinguished by the tip.
4
Comparison with Predicate Device:
A comparison of the ASAHI Corsair Armet 18 Microcatheter and predicate device shows that the technological characteristics of the ASAHI Corsair Armet 18 Microcatheter such as components, design, materials, sterilization method, shelf life and operating principle are identical or similar to the currently marketed predicate device.
The intended use/indications of the Subject Device are a subset of the predicate. There are specific design features of the Subject Device that are similar to the predicate, which has demonstrated equivalence for these similar features.
| Name of Device | ASAHI Corsair Armet | ASAHI Corsair Armet |
|---|---|---|
| 510(K) | (K161362) | Subject Device / Current |
| Application | ||
| Intended Use and | ||
| Indications | The ASAHI Corsair Armet is | |
| intended to provide support to | ||
| facilitate the placement of guide | ||
| wires in the peripheral | ||
| vasculature, and can be used to | ||
| exchange one guide wire for | ||
| another. | ||
| The ASAHI Corsair Armet is also | ||
| intended to assist in the delivery | ||
| of contract media into the | ||
| peripheral vasculature. | The ASAHI Corsair Armet 18 is | |
| intended to provide support to | ||
| facilitate the placement of guide | ||
| wires in the peripheral | ||
| vasculature, and can be used to | ||
| exchange one guide wire for | ||
| another. | ||
| The ASAHI Corsair Armet 18 is | ||
| also intended to assist in the | ||
| delivery of contract media into | ||
| the peripheral vasculature. | ||
| This device should not be used | ||
| in coronary vasculature or | ||
| neurovasculature. | This device should not be used | |
| in coronary vasculature or | ||
| neurovasculature. | ||
| Target Body Location | Peripheral | |
| Hydrophilic Coating | Yes | |
| Effective Length | 600-1500cm | 600-1350cm |
| Nominal Outer Diameter | Distal: 0.75mm | |
| Proximal: 0.83mm | Distal: 0.73mm | |
| Proximal: 0.87mm | ||
| Catheter Shaft Material | Polyamide-elastomer | |
| Distal Tip Length | 1.2mm | 1.50mm |
| Single Use | Yes | |
| Sterilization | Ethylene Oxide to SAL-6 | |
| Shelf life | 3 Years |
5
NON-CLINICAL TESTING / PERFORMANCE DATA;
Non Clinical Laboratory testing performed on the ASAHI Corsair Armet 18 Microcatheter to determine substantial equivalence:
- Air Leakage ●
- Appearance / Dimensions .
- Burst Pressure Under Static Condition ●
- Corrosion Resistance ●
- Kink Resistance .
- Liquid Leakage Under Pressure ●
- Radio-Detectability
- . Slide Durability
- Tensile Strength / Force at Break ●
- Torque Durability .
- Torque Transmission ●
In the in vitro bench tests demonstrated that the ASAHI Corsair Armet 18 Microcatheter met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrates that the device functions as intended, and is substantially equivalent to the predicate device.
All bench testing of the ASAHI Corsair Armet 18 Microcatheter performed on finished sterilized product. The acceptance criteria is based on ISO10555-1. Tests not conducted per ISO10555-1 were completed using in-house validated procedures with internally developed acceptance criteria.
All ASAHI Corsair Armet 18 Microcatheter test samples met the acceptance criteria for each of the tests listed in this submission. There were no deviations from the acceptance criteria. Testing shows that the ASAHI Corsair Armet 18 Microcatheter is equivalent to the predicate ASAHI Corsair Armet.
BIOCOMPATIBILITY:
The Biological Safety test of the ASAHI Corsair Armet 18 Microcatheter was not required. as the subject device did not change in material from its predicate device deeming biocompatibility testing unnecessary.
CONCLUSION:
The ASAHI Corsair Armet 18 Microcatheter has substantial identical intended use, the same similar technological characteristics such as components, design, materials, sterilization method, shelf life and operating principles as the predicate devices. Performance data demonstrates that the device functions as intended.
Therefore, the ASAHI Corsair Armet 18 Microcatheter is considered, substantially equivalent to the predicate device.